Tranexamic acid is a well-established treatment for post-partum hemorrhage. This study aims to examine the effect of tranexamic acid administration rates on blood pressure changes over 1 minute compared to 10 minutes in healthy pregnant patients scheduled for cesarean delivery.
Women who are clinically diagnosed with post-partum hemorrhage during a vaginal or cesarean delivery should be immediately administered tranexamic acid according to the World Health Organization's recommendation. Tranexamic acid is a drug that inhibits the breakdown of fibrin clots which reduces blood loss. However, due to the risk of hypotension, the product monograph for TXA advises against rapid intravenous (IV) administration. Other clinical studies have also reported an increased incidence of nausea, vomiting, and visual disturbances; nonetheless, the results of these trials suggest that these side effects may be related to properties of TXA rather than the rate of administration. Therefore, the investigators of this study aim to determine if the rate of tranexamic acid administration has an effect on blood pressure in healthy pregnant patients who are scheduled for cesarean delivery under spinal anesthesia.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
110
Study drug administration
BC Women's Hospital
Vancouver, British Columbia, Canada
RECRUITINGChange in systolic blood pressure from baseline over 15 minutes post-TXA administration between groups.
Change in systolic blood pressure from baseline over 15 minutes post-TXA administration between study and control groups
Time frame: 15 minutes starting from the time of completed TXA administration.
Incidence of nausea
sensation of self-reported nausea documented every 5 minutes.
Time frame: Up to 4 hours from time of TXA administration until time of discharge from the recovery room
Incidence of vomiting
vomiting documented every 5 minutes.
Time frame: Up to 4 hours from time of TXA administration until time of discharge from the recovery room
Incidence of hypotension
Incidence of systolic blood pressure reduction greater than or equal to 20% of baseline
Time frame: Up to 4 hours from time of TXA administration until time of discharge from the recovery room
Incidence of hypertension
Incidence of systolic blood pressure elevation greater than or equal to 20% of baseline
Time frame: Up to 4 hours from time of TXA administration until time of discharge from the recovery room
Incidence of central nervous system side effects
composite outcome of neurologic side effects including dizziness, headache, visual disturbances (photopsia) or facial flushing. These measures will be self-reported and documented every 5 minutes.
Time frame: Up to 4 hours from time of TXA administration until time of discharge from the recovery room
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